NDC 69336-353-30 HUMAN PRESCRIPTION DRUG

Drug Status:  Deprecated

Proprietary Name: Methaver

Drug Overview

The NDC Code 69336-353-30 is assigned to “Methaver ” (also known as: “Methaver”), a human prescription drug labeled by “Sterling-knight Pharmaceuticals,LLC”. The product's dosage form is capsule, and is administered via oral form.

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Drug Information
NDC Package Code	69336-353-30
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Product NDC	69336-353
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
11 Digit NDC Code	69336-0353-30
	It should be noted that many NDCs are displayed on drug packaging in a 10-digit format. Proper billing of an NDC requires an 11-digit number in a 5-4-2 format. Converting NDCs from a 10-digit to 11-digit format requires a strategically placed zero, dependent upon the 10-digit format.
Proprietary Name	Methaver
	Also known as the trade name. It is the name of the product chosen by the labeler.
Non Proprietary Name	Methaver
	Sometimes called the generic name, this is usually the active ingredient(s) of the product.
Product Type Name	HUMAN PRESCRIPTION DRUG
	Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Labeler Name	Sterling-knight Pharmaceuticals,LLC
	Name of Company corresponding to the labeler code segment of the ProductNDC.
Status	Deprecated
	Possible status values: Active Active NDC Code Deprecated Deprecated NDC Code Unfinished (Unapproved) The following status describes submitted unfinished drugs, including the marketing categories of Active Pharmaceutical Ingredient (API), Drug for Further Processing, Bulk for Human Drug Compounding, and Bulk for Animal Drug Compounding. FDA does not review and approve unfinished products. Therefore, all products having "unfinished" status are considered unapproved.
Description	Methaver is an orally administered prescription vitamin specifically formulated for the dietary management of patients with unique nutritional needs requiring increased folate levels, as well as other Vitamin B supplementation. Methaver should be administered under the supervision of a licensed medical practitioner. Each capsule contains the following ingredients. Each capsule contains:Folic Acid............................................................................1mgThiamin hydrochloride..……………………………………..27mgRiboflavin……………………………………………………..29mgPyridoxine hydrochloride..............,...................................50mgMethylcobalamin……………....….……………..……………2mg. Each capsule contains the following inactive ingredients: Lactose Monohydrate, Gelatin (bovine), Silicon Dioxide, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, FD&C Red #40. * This product is a prescription vitamin that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency. As such, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) as required by pedigree reporting requirements. FOLAT E REGULAT ION. The term "folate" are B vitamins that include folic acid and any forms of active pteroylglutamates regardless of the reduction state of the molecule. Folates, or vitamin B9, are primarily hydrolyzed in the intestinal jejunum and the liver to the active circulating form of folate. Folic acid, including reduced forms1 such as folinic acid, may obscure pernicious anemia above 0.1 mg doses, and must be administered under the supervision o f a licensed medical practitioner.
	General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Indication And Usage	Methaver is indicated for the distinct nutritional requirements of patients in need of dietary supplementation as determined by a licensed medical practitioner. Methaver should be administered under the supervision o f a licensed medical practitioner.
	A statement of each of the drug productÕs indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition.This field may also describe any relevant limitations of use.

Route & Dosage
Dosage Form Name	CAPSULE
	The translation of the DosageForm Code submitted by the firm. The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Route Name	ORAL
	The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Pharmaceutical Classes	VITAMIN B6 ANALOG [EPC],VITAMIN B 6 [CHEMICAL/INGREDIENT],ANALOGS/DERIVATIVES [CHEMICAL/INGREDIENT]
	These are the reported pharmaceutical class categories corresponding to the SubstanceNames listed above.

Substance & Strength
Substance Name	FOLIC ACID - 1 mg/1 RIBOFLAVIN - 29 mg/1 METHYLCOBALAMIN - 2 mg/1 THIAMINE HYDROCHLORIDE - 27 mg/1 PYRIDOXINE HYDROCHLORIDE - 50 mg/1
	This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

Drug Package Information
NDC Package Code	69336-353-30
	The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC.
Package Description	30 CAPSULE IN 1 BOTTLE, PLASTIC (69336-353-30)
	A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 BOTTLES in 1 CARTON/100 TABLETS in 1 BOTTLE.
Sample Package	N/S (NOT SPECIFIED)
	Defines whether given package serves sample purposes.
Package NDC Exclude Flag	N/S (NOT SPECIFIED)
	This indicates whether the package has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.
Package Start Marketing Date	N/S (NOT SPECIFIED)
	This is the date that the labeler indicates was the start of its marketing of the drug package.
Package End Marketing Date	N/S (NOT SPECIFIED)
	This is the date the package will no longer be available on the market. If a package is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Packages that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Packages with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

Product Application & Marketing Information
Product NDC	69336-353
	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Application Number	N/S (NOT SPECIFIED)
	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category Name	UNAPPROVED DRUG OTHER
	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Listing Record Certified Through	20171231
	This is the date when the listing record will expire if not updated or certified by the firm.
Product Marketing Start Date	20151124
	This is the date that the labeler indicates was the start of its marketing of the drug product.
Product Marketing End Date	N/S (NOT SPECIFIED)
	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Product NDC Exclude Flag	E
	This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

Tracking Information
Last Update Date	2018-04-20
	The date that a record was last updated or changed.